Cook Holmium Laser Fiber
FDA 510(k) K133788 · Cook Incorporated
510(k) numberK133788
Submission
- Device name
- Cook Holmium Laser Fiber
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- December 12, 2013
- Decision date
- March 18, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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Questions and answers
When was Cook Holmium Laser Fiber cleared by the FDA?
Cook Holmium Laser Fiber (K133788) received a 510(k) decision of Substantially Equivalent on March 18, 2015, 461 days after the submission was received.
What is the product code of K133788?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.